Energy Management for Adherent Patient Monitor

ABSTRACT

A heart failure patient management system includes a detecting system. The detecting system includes an adherent device configured to be coupled to a patient. The adherent device includes a plurality of sensors to monitor physiological parameters of the patient to determine heart failure status. At least one ID may be coupled to the adherent device that is addressable and unique to each adherent device. A wireless communication device is coupled to the plurality of sensors and configured to transfer patient data directly or indirectly from the plurality of sensors to a remote monitoring system. The remote monitoring system is coupled to the wireless communication device. An energy management device may be coupled to the plurality of sensors

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application claims the benefit under 35 USC 119(e) of U.S.Provisional Application Nos. 60/972,336, 60/972,537, 60/972,340 allfiled Sep. 14, 2007, 61/055,666 filed May 23, 2008, and 61/079,746 filedJul. 10, 2008; the full disclosures of which are incorporated herein byreference in their entirety.

The subject matter of the present application is related to thefollowing applications: Nos. 60/972,512; 60/972,329; 60/972,354;60/972,616; 60/972,363; 60/972,343; 60/972,581; 60/972,629; 60/972,316;60/972,333; 60/972,359; all of which were filed on Sep. 14, 2007;61/046,196 filed Apr. 18, 2008; 61/047,875 filed Apr. 25, 2008; and61/055,645, 61/055,656, 61/055,662 all filed May 23, 2008.

The following applications are being filed concurrently with the presentapplication, on Sep. 12, 2008: Attorney Docket Nos. 026843-000110USentitled “Multi-Sensor Patient Monitor to Detect Impending CardiacDecompensation Prediction”; 026843-000220US entitled “Adherent Devicewith Multiple Physiological Sensors”; 026843-000410US entitled“Injectable Device for Physiological Monitoring”; 026843-000510USentitled “Delivery System for Injectable Physiological MonitoringSystem”; 026843-000620US entitled “Adherent Device for Cardiac RhythmManagement”; 026843-000710US entitled “Adherent Device for RespiratoryMonitoring”; 026843-000810US entitled “Adherent Athletic Monitor”;026843-000910US entitled “Adherent Emergency Monitor”; 026843-001320USentitled “Adherent Device with Physiological Sensors”; 026843-001410USentitled “Medical Device Automatic Start-up upon Contact to PatientTissue”; 026843-001900US entitled “System and Methods for Wireless BodyFluid Monitoring”; 026843-002010US entitled “Adherent Cardiac Monitorwith Advanced Sensing Capabilities”; 026843-002410US entitled “AdherentDevice for Sleep Disordered Breathing”; 026843-002710US entitled“Dynamic Pairing of Patients to Data Collection Gateways”;026843-003010US entitled “Adherent Multi-Sensor Device with ImplantableDevice Communications Capabilities”; 026843-003110US entitled “DataCollection in a Multi-Sensor Patient Monitor”; 026843-003210US entitled“Adherent Multi-Sensor Device with Empathic Monitoring”; and026843-003410US entitled “Tracking and Security for Adherent PatientMonitor.”

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to systems and methods that usewireless physiological monitoring, and more particularly to systems andmethods for heart failure patient monitoring.

Frequent monitoring of patients permits the patients' physician todetect worsening symptoms as they begin to occur, rather than waitinguntil a critical condition has been reached. As such, home monitoring ofpatients with chronic conditions is becoming increasingly popular in thehealth care industry for the array of benefits it has the potential toprovide. Potential benefits of home monitoring are numerous and include:better tracking and management of chronic disease conditions, earlierdetection of changes in the patient condition, and reduction of overallhealth care expenses associated with long term disease management. Thehome monitoring of a number of diverse “chronic diseases” is ofinterest, where such diseases include diabetes, dietary disorders suchas anorexia and obesity, anxiety, depression, epilepsy, respiratorydiseases, AIDS and other chronic viral conditions, conditions associatedwith the long term use of immunosuppressants, e.g. in transplantpatients, asthma, chronic hypertension, chronic use of anticoagulants,and the like.

Of particular interest in the home monitoring sector of the health careindustry is the remote monitoring of patients with heart failure (HF),also known as congestive heart failure. HF is a syndrome in which theheart is unable to efficiently pump blood to the vital organs. Mostinstances of HF occur because of a decreased myocardial capacity tocontract (systolic dysfunction). However, HF can also result when anincreased pressure-stroke-volume load is imposed on the heart, such aswhen the heart is unable to expand sufficiently during diastole toaccommodate the ventricular volume, causing an increased pressure load(diasystolic dysfunction).

In either case, HF is characterized by diminished cardiac output and/ordamming back of blood in the venous system. In HF, there is a shift inthe cardiac function curve and an increase in blood volume caused inpart by fluid retention by the kidneys. Indeed, many of the significantmorphologic changes encountered in HF are distant from the heart and areproduced by the hypoxic and congestive effects of the failingcirculation upon other organs and tissues. One of the major symptoms ofHF is edema, which has been defined as the excessive accumulation ofinterstitial fluid, either localized or generalized.

HF is the most common indication for hospitalization among adults over65 years of age, and the rate of admission for this condition hasincreased progressively over the past two decades. It has been estimatedthat HF affects more than 3 million patients in the U.S. (J. B.O'Connell et al., J. Heart Lung Transpl. (1993) 13(4):S107-112).

In the conventional management of HF patients, where help is sought onlyin crisis, a cycle occurs where patients fail to recognize earlysymptoms and do not seek timely help from their care-givers, leading toemergency department admissions (Miller, P. Z., 1995, “Home monitoringfor congestive heart failure patients,” Caring Magazine, August 1995:53-54). Recently, a prospective, randomized trial of 282 patients wasconducted to assess the effect of the intervention on the rate ofadmission, quality of life, and cost of medical care. In this study, anurse-directed, multi disciplinary intervention (which consisted ofcomprehensive education of the patient and family, diet, social-serviceconsultation and planning, review of medications, and intensiveassessment of patient condition and follow-up) resulted in fewerreadmissions than the conventional treatment group and a concomitantoverall decrease in the cost of care (M. W. Rich et al., New Engl. J.Med. (1995) 333:1190-95).

Similarly, comprehensive discharge planning and a home follow-up programwas shown to decrease the number of readmissions and total hospitalcharges in an elderly population (M. Naylor et al., Amer. CollegePhysicians (1994) 120:999-1006). Therefore, home monitoring is ofparticular interest in the HF management segment of the health careindustry.

Another area in which home-monitoring is of particular interest is inthe remote monitoring of a patient parameter that provides informationon the titration of a drug, particularly with drugs that have aconsequential effect following administration, such as insulin,anticoagulants, ACE inhibitors, .beta.-blockers, diuretics, etc.

Although a number of different home monitoring systems have beendeveloped, there is continued interest in the development of newmonitoring systems. Of particular interest would be the development of asystem that provides for improved patient compliance, ease of use, etc.Of more particular interest would be the development of such a systemthat is particularly suited for use in the remote monitoring of patientssuffering from HF.

There is a need for an improved home monitoring of patients with chronicconditions. There is a further need for an improved HF monitoringsystem.

2. Description of the Background Art

The following U.S. Patents and Publications may describe relevantbackground art: U.S. Pat. Nos. 4,121,573; 4,955,381; 4,981,139;5,080,099; 5,353,793; 5,511,553; 5,544,661; 5,558,638; 5,724,025;5,772,586; 5,862,802; 5,944,659; 6,047,203; 6,117,077; 6,129,744;6,225,901; 6,385,473; 6,416,471; 6,454,707; 6,527,711; 6,527,729;6,551,252; 6,595,927; 6,595,929; 6,605,038; 6,645,153; 6,659,947;6,821,249; 6,980,851; 6,988,989; 7,020,508; 7,054,679; 7,130,396;7,153,262; 2003/0092975; 2004/0225199; 2005/0113703; 2005/0131288;2006/0010090; 2006/0031102; 2006/0074462; 2006/0089679; 2006/0122474;2006/0142820; 2006/0155183; 2006/0202816; 2006/0224051; 2006/0235281;2006/0264730; 2007/0015973; 2007/0021678; 2007/0038038; and2007/0180047.

BRIEF SUMMARY OF THE INVENTION

Accordingly, an object of the present invention is toprovide an improvedremote monitoring system of patients, for example patients with chronicconditions.

Another object of the present invention is to provide an improved remotemonitoring system for HF patients.

A further object of the present invention is to provide a remotemonitoring system for HF patients with at least one of an energymanagement device or at least one ID coupled to sensors to monitor apatient.

A further object of the present invention is to provide a remotemonitoring system for HF patients that uses outputs of a plurality ofsensors have multiple features to enhance physiological sensingperformance.

Another object of the present invention is to provide a remotemonitoring system for HF patients.

Still a further object of the present invention is to provide a remotemonitoring system for HF patients where heart failure status isdetermined by a weighted combination change in sensor outputs.

Yet another object of the present invention is to provide a remotemonitoring system for HF patients where heart failure status isdetermined when a rate of change of at least two sensor outputs is anabrupt change in the sensor outputs as compared to a change in thesensor outputs over a longer period of time.

A further object of the present invention is to provide a remotemonitoring system for HF patients where heart failure status isdetermined by a tiered combination of at least a first and a secondsensor output, with the first sensor output indicating a problem that isthen verified by at least a second sensor output.

Another object of the present invention is to provide a remotemonitoring system for HF patients where heart failure status isdetermined by a variance from a baseline value of sensor outputs.

Yet another object of the present invention is to provide a remotemonitoring system for HF patients where baseline values are defined by alook up table.

Still a further object of the present invention is to provide a remotemonitoring system for HF patients where heart failure status isdetermined when a first sensor output is at a high value that is greaterthan a baseline value, and at least one of a second a third sensoroutputs is at a high value also sufficiently greater than a baselinevalue to indicate heart failure status.

Another object of the present invention is to provide a remotemonitoring system for HF patients where heart failure status isdetermined by time weighting the outputs of at least first, second andthird sensors, and the time weighting indicates a recent event that isindicative of the heart failure status.

These and other objects of the present invention can be achieved in manyembodiments comprising a patient monitoring system that includes adetecting system. The detecting system has, (i) an adherent deviceconfigured to be coupled to a patient, the adherent device including aplurality of sensors that monitors physiological parameters of thepatient, for example physiological parameters to determine heart failurestatus, (ii) at least one ID coupled to the adherent device that isaddressable and unique to each adherent device, and (iii) a wirelesscommunication device coupled to the plurality of sensors and configuredto transfer patient data from the plurality of sensors to a remotemonitoring system. The remote monitoring system is coupled to thewireless communication device. An energy management device may becoupled to the plurality of sensors so as to minimize power consumptionwhen the patch is worn by the patient.

In a first aspect, embodiments of the present invention provide a systemfor monitoring a patient. The system comprises a patient detectingsystem and a remote monitoring system. The patient detecting system canmeasure the patient and includes an adherent device configured to becoupled to a patient. The adherent device comprises a plurality ofsensors to measure physiological parameters of the patient to determinephysiologic status of the patient. The patient detecting system alsoincludes an energy management device coupled to the plurality of sensorsand a wireless communication device coupled to the plurality of sensors.The remote monitoring system is coupled to the wireless communicationdevice and is configured to transfer patient data from the plurality ofsensors to the remote monitoring system.

In many embodiments, an energy generation device is coupled to theenergy management device.

In many embodiments, the energy management device is part of the patientdetecting system. The adherent device may be configured to sampleintermittently. For example, the plurality of sensors may be configuredto sample no more than 30 seconds for every minute for ECG, no more thanonce per second for an accelerometer sensor and no more than 60 secondsfor every 15 minutes for impedance.

The plurality of sensors may be configured to measure at least one ofbioimpedance, heart rate, heart rhythm, HRV, HRT, heart sounds,respiratory sounds, blood pressure, activity, posture, wake/sleep,orthopnea, temperature, heat flux or patient activity. The plurality ofsensor may be configured to measure the patient activity with at leastone of a ball switch, an accelerometer, minute ventilation, heart rate,bioimpedance, noise, skin temperature, heat flux, blood pressure, musclenoise or patient posture.

In many embodiments, the plurality of sensors is configured to switchbetween different modes. The different modes comprise a first mode and asecond mode, the first mode different from the second mode.

The energy management device may be configured to deactivate selectedsensors to reduce redundancy and reduce power consumption. The energymanagement device may be configured to use sensor cycling for energymanagement. The plurality of sensors may comprise a first portion ofsensors and a second portion of sensors. The first portion can beconfigured to sample at first times and the second portion can beconfigured to sample at second times. The first times may be differentfrom the second times, and the energy management device may beconfigured to cycle sampling between the first sensors and the secondsensors.

The plurality of sensors may comprise a first core sensor and a secondsensor. The first core sensor is configured to continuously monitor anddetect while the second sensor is configured to verify a physiologicalstatus in response to the core sensor raising a flag. The plurality ofsensors may comprise a first portion and a second portion. The firstportion is different from the second portion. The first portion isconfigured for short term tracking and the second portion of the sensorsis configured for long term tracking.

The adherent device may be configured to be activated. The adherentdevice may be activated by at least one of a physiological trigger,automatic impedance, a tab pull, battery insertion, a hall or reedswitch, a breakable glass capsule, a dome switch, by light activation,pressure activation, body temperature activation, a connection betweenelectronics associated with the sensors and the adherent device,exposure to air and by a capacitive skin sensor.

The energy management device may be configured to perform at least oneof modulate a clock speed to optimize energy, monitor cell voltagedrop—unload cell, monitor coulomb-meter or other battery monitor,battery end of life dropoff to transfer data, elective replacementindicator, call center notification, sensing windows by the sensorsbased on a monitored physiological parameter or sensing rate control.The energy generation device may be configured to generate energy by atleast one of a thermo-electric unit, kinetics, fuel cell, through solarpower, a zinc air interface, Faraday generator, internal combustion, amicro-battery and with a rechargeable device.

In many embodiments, the system further comprises a processor. Theprocessor comprises a tangible medium coupled to the plurality ofsensors and to the wireless communication device. The processor isconfigured to receive patient data from the plurality of sensors andprocess the patient data. The processor may be located at the remotemonitoring system. The processor may be included in a monitoring unit,which comprises part of the patient detecting system. Logic resourcesmay be located at the monitoring unit. These logic resources determine aphysiological event of a patient.

In many embodiments, the system further comprises logic resourceslocated at the remote monitoring system. These logic resources maydetermine a physiological status of the patient and detect aphysiological event of a patient.

In many embodiments, the system further comprises a processor system.The processor system comprises a tangible medium and has programinstructions for evaluating values received from the plurality ofsensors with respect to acceptable physiological ranges for each valuereceived by the processor.

The wireless communication device may be configured to receiveinstructional data from the remote monitoring system. The wirelesscommunication device may comprise at least one of a modem, a serialinterface, a LAN connection and a wireless transmitter. The wirelesscommunication device may include a receiver and a transmitter forreceiving data indicating the values of the physiological event detectedby the plurality of sensors, and for communicating the data to theremote monitoring system. The wireless communication device may comprisea wireless local area network for receiving data from the plurality ofsensors. The wireless communication device may include a data storagefor recording the data received from the plurality of sensors. Thewireless communication device may include an access device for enablingaccess to information recorded in the data storage from the remotemonitoring system. The wireless communication device may include acontroller configured to control sending of the data supplied by theplurality of sensors.

In many embodiments, the system further comprises an external devicecoupled to the adherent device comprising the plurality of sensors. Theexternal device may comprise at least one of a weight scale, a bloodpressure cuff, a medical treatment device or a medicament dispenser.

In many embodiments, the system further comprises a notification devicecoupled to the patient detecting system and the remote monitoringsystem. The notification device is configured to provide a notificationwhen values received from the plurality of sensors are outsideacceptable physiological ranges. The patient measurement system may beconfigured to measure physiological parameters at a high-rate ofsampling in response to a trigger from at least one of a medicalprovider, the remote monitoring system or a medical treatment device.The at least one of the medical provider, the remote monitoring systemor the medical treatment device are configured to trigger the high-rateof sampling of the physiological parameters for alert verification. Thenotification device may be configured to communicate with the at leastone of the patient, a clinician, a spouse, a family member, a caregiveror a medical provider when the values received from the plurality ofsensors are not within acceptable physiological ranges. The notificationdevice may further be configured to communicate from one device toanother device, thereby allowing for therapeutic intervention to preventdecompensation when the values received from the plurality of sensorsare not within acceptable physiological ranges.

In many embodiments, the system further comprises a memory managementdevice. The memory management device is configured to perform at leastone of data compression, prioritizing of sensing by a sensor, monitoringat least some from at least some of the sensors, sensing by the sensorsin real time, noise blanking such that sensor data is not stored whennoise above a selected level is determined, low-power of battery cachingor decimation of old sensor data.

The adherent device may comprise a wearable patch that includes abattery.

The physiological status of the patient may comprise a heart failurestatus. At least one of the patient detecting system or the remotemonitoring system may comprise a processor system configured todetermine the heart failure status of the patient in response to thephysiological parameters.

The plurality of sensors may comprise a combination of at least twosensors configured to detect or predict decompensation. The combinationmay be configured to measure at least two of an electrocardiogramsignal, a hydration signal, an accelerometer signal or a respirationsignal of the patient.

The remote monitoring system may include a receiver, a transmitter and adisplay for displaying data representative of values of at least onephysiological event detected by the plurality of sensors.

The remote monitoring system may include a data storage mechanism and acomparator. The data storage mechanism has a plurality of acceptableranges for physiological values stored therein. The comparator comparesthe data received from the monitoring system with the acceptable rangesstored in the data storage device.

The remote monitoring system may include a portable computer. The remotemonitoring system may comprise a portable unit having a display screenand a data entry device for communicating with the wirelesscommunication device.

In another aspect, embodiments of the invention provide a device formonitoring a patient. The device comprises an adherent device comprisinga plurality of sensors, sensor circuitry coupled to the plurality ofsensors, wireless circuitry and energy management circuitry. Theadherent device is configured to couple to a skin of the patient. Thesensor circuitry comprises electrocardiogram circuitry, bioimpedancecircuitry, accelerometer circuitry, and temperature sensor circuitry.The power management device is coupled to the wireless circuitry andconfigured to transmit data from the sensor circuitry with a wirelesscircuitry duty cycle of no more than about 5%.

In many embodiments, the device is configured to monitor continuously apatient health status in response to the plurality of sensors.

In many embodiments, the patient may comprise a heart failure patientand the adherent device is configured to continuously monitor the heartfailure status with the wireless circuitry duty cycle of no more thanabout 5%.

In many embodiments, a majority of the sensor circuitry comprises a dutycycle of no more than about 5%. For example, the electrocardiogramcircuitry may comprise a duty cycle of no more than about 40%; thebioimpedance circuitry may comprise a duty cycle of no more than about10%; the accelerometer circuitry may comprise a duty cycle of no morethan about 1%; and the temperature sensor circuitry may comprise a dutycycle of no more than about 1%.

The power management device may comprise a timer coupled to the sensorcircuitry to determine the duty cycle of each sensor.

In many embodiments, the device further comprises a processor. Theprocessor comprises a tangible medium coupled to the sensor circuitryand is configured with the timer to sample data from the sensorcircuitry. The adherent device is configured to support the processor,the plurality of sensors, the sensor circuitry, the wireless circuitryand the energy management circuitry with the skin of the patient.

In many embodiments, the processor is configured to determine a heartrate of the patient in response to the electrocardiogram circuitry. Theprocessor may also be configured to determine a respiration of thepatient in response to the bioimpedance circuitry.

In many embodiments, the device further comprises a processor system.The processor system comprises the processor and a second processor at aremote location. The second processor is wirelessly coupled to theprocessor supported with adherent device. The processor system isconfigured to detect decompensation of a heart failure patient inresponse to output from the plurality of sensors. The second processorat the remote location may be configured to combine the output from theplurality of sensors detect the decompensation of the heart failurepatient. The second processor at the remote location can be configuredto determine a respiration rate of the patient at the remote location inresponse to the bioimpedance circuitry.

In many embodiments, the device comprises at least one batteryconfigured to power the electrocardiogram circuitry, the bioimpedancecircuitry and the accelerometer circuitry and the temperature sensorcircuitry for at least about one week when the adherent device isadhered to the skin of the patient. The adherent device may beconfigured to consume no more than about 1500 mA Hours per day when theadherent device is adhered to the patient for an extended period of atleast about one week.

In another aspect, embodiments of the present invention provide a methodfor monitoring a patient. The method comprises adhering an adherentdevice to a skin of the patient. The adherent device comprises aplurality of sensors. Patient data are measured with sensor circuitrycoupled to the plurality of sensors. The sensor circuitry comprises atleast one of electrocardiogram circuitry, bioimpedance circuitry,accelerometer circuitry, or temperature sensor circuitry. The patientdata is transmitted with wireless transmission circuitry supported theskin of the patient to a remote monitoring system. The wirelesstransmission circuitry transmits the patient data intermittently with aduty cycle of no more than about 5%.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating one embodiment of a patientmonitoring system of the present invention;

FIGS. 2A and 2B illustrate exploded view and side views of embodimentsof an adherent device with sensors configured to be coupled to the skinof a patient for monitoring purposes;

FIG. 3 illustrates one embodiment of an energy management device that iscoupled to the plurality of sensors of FIG. 1;

FIG. 4 illustrates one embodiment of present invention illustratinglogic resources configured to receive data from the sensors and/or theprocessed patient for monitoring purposes, analysis and/or predictionpurposes;

FIG. 5 illustrates an embodiment of the patient monitoring system of thepresent invention with a memory management device;

FIG. 6 illustrates an embodiment of the patient monitoring system of thepresent invention with an external device coupled to the sensors;

FIG. 7 illustrates an embodiment of the patient monitoring system of thepresent invention with a notification device;

FIG. 8 is a block diagram illustrating an embodiment of the presentinvention with sensor leads that convey signals from the sensors to amonitoring unit at the detecting system, or through a wirelesscommunication device to a remote monitoring system;

FIG. 9 is a block diagram illustrating an embodiment of the presentinvention with a control unit at the detecting system and/or the remotemonitoring system;

FIG. 10 is a block diagram illustrating an embodiment of the presentinvention where a control unit encodes patient data and transmits it toa wireless network storage unit at the remote monitoring system;

FIG. 11 is a block diagram illustrating one embodiment of an internalstructure of a main data collection station at the remote monitoringsystem of the present invention; and

FIG. 12 is a flow chart illustrating an embodiment of the presentinvention with operation steps performed by the system of the presentinvention in transmitting information to the main data collectionstation.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the present invention comprise an adherent multi-sensorpatient monitor capable of tracking a patient's physiological status.The monitor can be configured for and detecting and predictingphysiological events, for example negative physiological events. Thedevice may comprise an intelligent combination of sensors to enhancedetection and prediction capabilities, for example to detect cardiacdecompensation.

Decompensation is failure of the heart to maintain adequate bloodcirculation. Although the heart can maintain at least some pumping ofblood, the quantity is inadequate to maintain healthy tissues. Severalsymptoms can result from decompensation including pulmonary congestion,breathlessness, faintness, cardiac palpitation, edema of theextremities, and enlargement of the liver. Cardiac decompensation canresult in slow or sudden death. Sudden Cardiac Arrest (hereinafter“SCA”), also referred to as sudden cardiac death, is an abrupt loss ofcardiac pumping function that can be caused by a ventricular arrhythmia,for example ventricular tachycardia and/or ventricular fibrillation.Although decompensation and SCA can be related in that patients withdecompensation are also at an increased risk for SCA, decompensation isprimarily a mechanical dysfunction caused by inadequate blood flow, andSCA is primarily an electrical dysfunction caused by inadequate and/orinappropriate electrical signals of the heart.

The combination of sensors can be used to detect cardiac decompensation,which can be difficult to diagnose in the early stages.

The adherent patch device may comprise an energy management deviceconfigured with a variety of energy management features. The energymanagement device comprises circuitry configured for energy management,for example at least one of timer circuitry, processor circuitry, orprogrammable array logic (PAL) circuitry. The energy management devicemay be configured with at least one of the following:

-   1. Patch activation    -   a. Patch can be activated    -   b. Mechanism for removing from storage mode    -   i. Automatic impedance/physiological variable trigger    -   ii. Tab pull (e.g. integrated into package)    -   iii. Battery insertion    -   iv. Hall/reed switch    -   v. Breakable glass capsule    -   vi. Dome switch    -   vii. Light activated (storage in opaque package)    -   viii. Pressure activated (storage in vacuum sealed package)    -   ix. Temperature (body temperature activated)    -   x. Temp/activity/physiological variable within range    -   xi. Connection between electronics and patch    -   xii. Exposure to air (zinc-air battery, etc.)    -   xiii. Capacitive skin sensor-   2. Intermittent sampling-   3. Data management    -   a. Data compression    -   b. Prioritizing sensor data—all sensors monitored in real        time—subset of sensors stored for report    -   c. Noise blanking    -   d. Low-power caching    -   e. Decimate old data    -   f. EOC dropoff to transfer data    -   g. ERI: call center notification-   4. Power/energy generation/storage    -   a. Thermo-electric unit    -   b. Kinetic    -   c. Fuel cell    -   d. Solar powered    -   e. Zinc-air    -   f. Faraday generator    -   g. Internal combustion    -   h. Nuclear powered    -   i. Micro-battery    -   j. Acoustic    -   k. Inductive    -   l. Rechargeable-   5. Energy management    -   a. Modulate clock speed to optimize energy    -   b. Physiological (e.g. sleep) control of sensors—duty cycle,        sample rate control (based on always-on sensor)-   6. Energy monitoring    -   a. Monitor cell voltage drop—unload cell    -   b. Monitor coulomb-meter or other battery monitor

In one embodiment, illustrated in FIG. 1, the present invention is apatient management system, generally denoted as 10, that tracks thepatient's physiological status, detects and predicts negativephysiological events. In one embodiment, a plurality of sensors are usedin combination to enhance detection and prediction capabilities as morefully explained below.

Embodiments may comprise a patient management system comprising anadherent patch that is applied to the patient, for example formonitoring heart failure patients. The patch can be configured tomonitor physiological patient parameters, communicates wirelessly with aremote center, and provides alerts when necessary. The patientmanagement system may comprise a variety of tracking and securitydevices.

The heart failure patient management system can monitor physiologicalparameters and uses algorithms to determine heart failure status and anpredict impending cardiac decompensation. The system comprises anadherent patch device with wireless communication capabilities. Thepatch device is configured to communicate with a remote center, forexample via an intermediate device in the patient's home.

The adherent patch device may be tagged with a sensor ID, which isaddressable and unique to each patch. This ID may be transmitted to theremote sensor with the data stream, and can be used to associate thedata with the particular patch system. If multiple disposable patchesare used by the same patient, the multiple patches may be linked as aset, and replacement patches linked to the original set. At thehospital, when the patch set is given to the patient, the nurse mayregister via a web site and upload patient info onto patch, for exampleusing a hospital unit with scanner and wireless connection to patch.

The modem may be assigned to the patient, which then links to the patchset. A particular modem can be configured to only communicate with aspecific patch set, which is associated with a specific patient.Registration with the remote center may occur automatically.

The patch may be associated with a patient using caller ID (to determinethe source of the modem communication, using an RFID tag on the patient,for example an implant or second patch, a body tattoo, a fingerprint ID,or GPS. A removable memory component, for example containing a uniquetag, may be reused as the patches are replaced.

To enhance security, a tamper-proof electronics housing may be used withthe adherent patch device.

The adherent patch device may also produce two different outputs,protected patient data with restricted communication and general deviceand/or patient information for general communication. The restrictedcommunication may require additional security verification. Therestricted communication may be encrypted, while general communicationis not.

Additional security mechanism may include: skin tattoo with patchreader, modem identification, encrypted communication, encrypted datastorage on the device, biometric ID, and x-ray ID tags.

In the embodiments illustrated in FIG. 1, a patient management system,generally denoted as 10, tracks the patient's physiological status,detects and predicts negative physiological events. In one embodiment, aplurality of sensors are used in combination to enhance detection andprediction capabilities as more fully explained below.

In one specific embodiment, the system 10 is used for decompensationprediction of a heart failure patient. For example system 10 maycomprise a heart failure patient management system used fordecompensation prediction of a heart failure patient. System 10comprises a detecting system, for example a patient measuring system,denoted as 12, and a remote monitoring system 18. The detecting systemcomprises an adherent device configured to couple to the patient, forexample configured to adhere to the patient's skin.

The adherent device comprises a plurality of sensors 14. The pluralityof sensors can measure physiological parameters of the patient tomonitor the patient and determine the status of the patient, for exampleto determine heart failure status. The physiological parameters canprovide an indication of at least one physiological event, for example acardiac decompensation or an impending cardiac decompensation. Theplurality of sensors may be coupled to the patient, for example adheredto the patient's thorax. The adherent device may be housed in a tamperproof housing prior to placement on the patient.

The logic circuitry, or resources, can be configured in many ways todetect the at least one physiological event, such as heart failure. Forexample, the remote monitoring system may comprise the logic circuitry,and the remote monitoring system may determine HF status when a rate ofchange of at least two sensor outputs comprises an abrupt change in thesensor outputs, such as an abrupt change as compared to a change in thesensor outputs over a longer period of time. The remote monitoringsystem may determine HF status by a tiered combination of at least afirst and a second sensor output, with the first sensor outputindicating a problem that is then verified by at least a second sensoroutput. The remote monitoring system may determine HF status in responsea variance from a baseline value of sensor outputs. In some embodiments,the baseline values may be defined by a look up table. The HF status maybe determined when a first sensor output is at a high value that isgreater than a baseline value, and at least one of a second or a thirdsensor outputs is at a high value also sufficiently greater than abaseline value to indicate heart failure status. Heart failure statusmay be determined by time weighting the outputs of at least first,second and third sensors, and the time weighting indicates a recentevent that is indicative of the heart failure status. When the patientmeasuring system comprises the logic circuitry, the patient measuringsystem may similarly detect the at least one physiological event.

The detecting system 12 also includes a wireless communication device16, coupled to the plurality of sensors 14. The wireless communicationdevice transfers patient data directly or indirectly from the pluralityof sensors 14 to a remote monitoring system 18. The remote monitoringsystem 18 uses data from the sensors to determine heart failure statusand predict impending decompensation of the patient. The detectingsystem 12 can continuously, or non-continuously, monitor the patient,alerts are provided as necessary and medical intervention is providedwhen required. The wireless communication device 16 may comprise atleast one of a gateway or a wireless local area network for receivingdata from the plurality of sensors.

The plurality of sensors 14 may comprise at least one ID sensor. The atleast one ID sensor may be coupled to the adherent device, addressable,and unique to each adherent device. The adherent device may comprise theID sensor of the plurality of sensors 14.

FIGS. 2A and 2B show embodiments of the plurality of sensors 14supported with an adherent device 200 configured to adhere to the skin.Adherent device 200 is described in U.S. App. No. 60/972,537, the fulldisclosure of which has been previously incorporated herein byreference. As illustrated in an exploded view of the adherent device, acover 262, batteries 250, electronics 230, including but not limited toflex circuits and the like, an adherent tape 210T, the plurality ofsensors may comprise electrodes and sensor circuitry, and hydrogelswhich interface the plurality of sensors 14 with the skin, are provided.

Adherent device 200 comprises a support, for example adherent patch 210,configured to adhere the device to the patient. Adherent patch 210comprises a first side, or a lower side 210A, that is oriented towardthe skin of the patient when placed on the patient and a second side, orupper side 210B, opposite of the first side. In many embodiments,adherent patch 210 comprises a tape 210T which is a material, preferablybreathable, with an adhesive 216A. Patient side 210A comprises adhesive216A to adhere the patch 210 and adherent device 200 to patient P.Electrodes 212A, 212B, 212C and 212D are affixed to adherent patch 210.In many embodiments, at least four electrodes are attached to the patch,for example six electrodes. In some embodiments the patch comprises twoelectrodes, for example two electrodes to measure the electrocardiogram(ECG) of the patient. Gel 214A, gel 214B, gel 214C and gel 214D can eachbe positioned over electrodes 212A, 212B, 212C and 212D, respectively,to provide electrical conductivity between the electrodes and the skinof the patient. In many embodiments, the electrodes can be affixed tothe patch 210, for example with known methods and structures such asrivets, adhesive, stitches, etc. In many embodiments, patch 210comprises a breathable material to permit air and/or vapor to flow toand from the surface of the skin. In some embodiments, a printed circuitboard (PCB), for example flex PCB 220, may be connected to upper side210B of patch 210 with connectors. In some embodiments, additionalPCB's, for example rigid PCB's 220A, 220B, 220C and 220D, can beconnected to flex PCB 220. Electronic components 230 can be connected toflex PCB 220 and/or mounted thereon. In some embodiments, electroniccomponents 230 can be mounted on the additional PCB's.

Electronic circuitry and components 230 comprise circuitry andcomponents to take physiologic measurements, transmit data to remotecenter and receive commands from remote center. In many embodiments,electronics components 230 may comprise known low power circuitry, forexample complementary metal oxide semiconductor (CMOS) circuitrycomponents. Electronics components 230 comprise an activity sensor andactivity circuitry, impedance circuitry and electrocardiogram circuitry,for example ECG circuitry. In some embodiments, electronics circuitrymay comprise a microphone and microphone circuitry to detect an audiosignal from within the patient, and the audio signal may comprise aheart sound and/or a respiratory sound, for example an S3 heart soundand a respiratory sound with rales and/or crackles. Electronicscircuitry and components 230 may comprise a temperature sensor, forexample a thermistor, and temperature sensor circuitry to measure atemperature of the patient, for example a temperature of a skin of thepatient.

A cover 262 can extend over the batteries, electronic components andflex printed circuit board. In many embodiments, an electronics housing260 may be disposed under cover 262 to protect the electroniccomponents, and in some embodiments electronics housing 260 may comprisean encapsulant over the electronic components and PCB. In someembodiments, cover 262 can be adhered to the adhesive patch with anadhesive. In many embodiments, electronics housing 260 may comprise awater proof material, for example a sealant adhesive such as epoxy orsilicone coated over the electronics components and/or PCB. In someembodiments, electronics housing 260 may comprise metal and/or plastic.Metal or plastic may be potted with a material such as epoxy orsilicone. Cover 262 may comprise many known biocompatible cover, casingand/or housing materials, such as elastomers, for example silicone. Theelastomer may be fenestrated to improve breathability. In someembodiments, cover 262 may comprise many known breathable materials, forexample polyester, polyamide, and/or elastane (Spandex). The breathablefabric may be coated to make it water resistant, waterproof, and/or toaid in wicking moisture away from the patch.

Adherent device 200 comprises several layers. Gel 214A, or gel layer, ispositioned on electrode 212A to provide electrical conductivity betweenthe electrode and the skin. Electrode 212A may comprise an electrodelayer. Adhesive patch 210 may comprise a layer of breathable tape 210T,for example a known breathable tape, such as tricot-knit polyesterfabric. In many embodiments, a gap 269 extends from adhesive patch 210to the electronics circuitry and components 230, such that breathabletape 210T can breath to provide patient comfort. An adhesive 216A, forexample a layer of acrylate pressure sensitive adhesive, can be disposedon underside 210A of patch 210. A gel cover 280, or gel cover layer, forexample a polyurethane non-woven tape, can be positioned over patch 210comprising the breathable tape. A PCB layer, for example flex PCB 220,or flex PCB layer, can be positioned over gel cover 280 with electroniccomponents 230 connected and/or mounted to flex PCB 220, for examplemounted on flex PCB so as to comprise an electronics layer disposed onthe flex PCB. In many embodiments, the adherent device may comprise asegmented inner component, for example the PCB, for limited flexibility.In many embodiments, the electronics layer may be encapsulated inelectronics housing 260 which may comprise a waterproof material, forexample silicone or epoxy. In many embodiments, the electrodes areconnected to the PCB with a flex connection, for example trace 223A offlex PCB 220, so as to provide strain relive between the electrodes212A, 212B, 212C and 212D and the PCB. Gel cover 280 can inhibit flow ofgel 214A and liquid. In many embodiments, gel cover 280 can inhibit gel214A from seeping through breathable tape 210T to maintain gel integrityover time. Gel cover 280 can also keep external moisture frompenetrating into gel 214A. Gel cover 280 may comprise at least oneaperture 280A sized to receive one of the electrodes. In manyembodiments, cover 262 can encase the flex PCB and/or electronics andcan be adhered to at least one of the electronics, the flex PCB or theadherent patch, so as to protect the device. In some embodiments, cover262 attaches to adhesive patch 210 with adhesive 216B. Cover 262 cancomprise many known biocompatible cover, housing and/or casingmaterials, for example silicone. In many embodiments, cover 262comprises an outer polymer cover to provide smooth contour withoutlimiting flexibility. In some embodiments, cover 262 may comprise abreathable fabric. Cover 262 may comprise many known breathable fabrics,for example breathable fabrics as described above. In some embodiments,the breathable fabric may comprise polyester, polyamide, and/or elastane(Spandex™) to allow the breathable fabric to stretch with body movement.In some embodiments, the breathable tape may contain and elute apharmaceutical agent, such as an antibiotic, anti-inflammatory orantifungal agent, when the adherent device is placed on the patient.

In one embodiment, the wireless communication device 16 is configured toreceive instructional data from the remote monitoring system.

Referring to FIG. 3, an energy management device 19 can be coupled tothe plurality of sensors. In one embodiment, the energy managementdevice 19 is part of the detecting system. In various embodiments, theenergy management device 19 performs one or more of modulate a clockspeed to optimize energy, monitor cell voltage drop—unload cell, monitorcoulomb-meter or other battery monitor, battery end of life dropoff totransfer data, elective replacement indicator, call center notification,sensing windows by the sensors 14 based on a monitored physiologicalparameter and sensing rate control.

In one embodiment, energy management is achieved by using time as avariable. This can be achieved by intermittent sampling. Variable timecourses can be used for measuring signals from the beginning and theduty cycle rates can be adjusted, for example adjusted at the remotemonitoring system 18.

In one embodiment, the energy management device 19 is configured togenerate energy by at least one of, a thermo-electric unit, kinetics,fuel cell, through solar power, a zinc air interface, Faraday generator,internal combustion, nuclear power, a micro-battery and with arechargeable device.

Referring again to FIG. 1, the adherent device may include a patch setconfigured to be coupled to the patient. Patches in the patch set, aswell as replacement patches can be linked together and coupled tohardware at the detecting system 12 or at the remote monitoring system18. Patches of the patch set can also be linked at software at a backend at the remote monitoring system 18. Registration with the remotemonitoring system 18 can occur each time a new patch is put on thepatient.

When an adherent device is provided to a patient, a medical providerregisters that adherent device, associated with that patient, with theremote monitoring system 18. Registration can take place a variety ofdifferent ways, including but not limited to, via a web site, and thelike. Upon registration, patient data is uploaded to the adherentdevice. An association of the adherent patch with the patient occurs byat least one of, caller ID, an RFID tag on the patient, a body tattoo,fingerprint ID and GPS.

In one embodiment, a modem is assigned to the patient and links to theadherent device. The modem can be configured to determine which patch issending information to the modem. The modem communicates only with thepatch set of the patient, and the modem only communicates with thosepatches with which it is associated. The modem can be at the detectingsystem 12 or at the remote monitoring system 18.

In one embodiment, the ID sensor 14 has a removable memory componentwith a unique patient ID that is reused as patches of the patch set arereplaced. In one embodiment, the ID sensor 14 produces a first outputthat has protected patient data with restricted communication, and asecond output that has general device and patient information forgeneral communication. Access to the protected patient data can requirean additional security verification. At least a portion of the protectedpatient data can be encrypted. A variety of additional securityverifications including but not limited to, a skin tattoo with anadherent device reader, a modem identification, an encryptedcommunication, an encrypted data storage on the adherent device, abiometric ID, an x-ray ID tag and the like.

The system 10 is configured to automatically detect events. The system10 automatically detects events by at least one of, high noise states,physiological quietness, sensor continuity and compliance. In responseto a detected physiological event, patient states are identified whendata collection is inappropriate. In response to a detectedphysiological event, patient states are identified when data collectionis desirable. Patient states include, physiological quietness, rest,relaxation, agitation, movement, lack of movement and a patient's higherlevel of patient activity.

The system can use an intelligent combination of sensors to enhancedetection and prediction capabilities, as more fully discloses in U.S.patent application Ser. No. 60/972,537, identified as Attorney DocketNo. 026843-000200US, filed Sep. 14, 2007, the full disclosure of whichhas been previously incorporated herein by reference, and as more fullyexplained below. The intelligent combination of sensors may comprise asensor to measure at least two of an electrocardiogram signal, ahydration signal, an accelerometer signal or a respiration signal of thepatient.

In one embodiment, the detecting system 12 communicates with the remotemonitoring system 18 periodically or in response to a trigger event. Thetrigger event can include but is not limited to at least one of, time ofday, if a memory is full, if an action is patient initiated, if anaction is initiated from the remote monitoring system, a diagnosticevent of the monitoring system, an alarm trigger, a mechanical trigger,and the like.

The adherent device be activated by a variety of different meansincluding but not limited to, a physiological trigger, automaticimpedance, a tab pull, battery insertion, a hall or reed switch, abreakable glass capsule, a dome switch, by light activation, pressureactivation, body temperature activation, a connection betweenelectronics associated with the sensors and the adherent device,exposure to air, by a capacitive skin sensor and the like.

The detecting system 12 can continuously, or non-continuously, monitorthe patient, alerts are provided as necessary and medical interventionis provided when required. In one embodiment, the wireless communicationdevice 16 is a wireless local area network for receiving data from theplurality of sensors.

A processor 20 is coupled to the plurality of sensors 14 and can also bea part of the wireless communication device 16. The processor 20comprises at least one tangible medium and may comprise a processorsystem. The processor 20 receives data from the plurality of sensors 14and creates processed patient data.

In many embodiments, the processor 20 comprises at least one of aprocessor of detecting system 12 comprising a tangible medium, aprocessor of remote monitoring system 18 comprising a tangible medium, aprocessor of wireless communication device 16 comprising a tangiblemedium or a processor of monitoring unit 22 comprising a tangiblemedium. In one embodiment, the processor 20 is located at the remotemonitoring system. In another embodiment, the processor 20 is located atthe detecting system 12.

The processor 20 can be integral with a monitoring unit 22 that is partof the detecting system 12 or part of the remote monitoring system, orboth. The monitoring unit can be located at the remote monitoring system18.

The processor 20 has program instructions for evaluating values receivedfrom the sensors 14 with respect to acceptable physiological ranges foreach value received by the processor 20 and determine variances. Theprocessor 20 can receive and store a sensed measured parameter from thesensors 14, compare the sensed measured value with a predeterminedtarget value, determine a variance, accept and store a new predeterminedtarget value and also store a series of questions from the remotemonitoring system 18.

As shown in FIG. 4, logic resources 24 are provided that take the datafrom the sensors 14, and/or the processed patient data from theprocessor 20, to predict an impending decompensation. The logicresources 24 can be at the remote monitoring system 18 or at thedetecting system 12, such as in the monitoring unit 22.

In one embodiment, illustrated in FIG. 5, a memory management device 25is provided. In various embodiments, the memory management device 25performs one or more of data compression, prioritizing of sensing by asensor 14, monitoring all or some of sensor data by all or a portion ofsensors 14, sensing by the sensors 14 in real time, noise blanking toprovide that sensor data is not stored if a selected noise level isdetermined, low-power of battery caching and decimation of old sensordata.

The sensors 14 can have associated circuitry, e.g. processor 20, whichcan provide a variety of different functions, including but not limitedto, initiation, programming, measuring, storing, analyzing,communicating, predicting, and displaying of a physiological event ofthe patient. Each of sensors 14 is preferably sealed, such as housed ina hermetically sealed package. In one embodiment, at least a portion ofthe sealed packages include a power source, a memory, logic resourcesand a wireless communication device. In one embodiment, the sensors 14can include, flex circuits, thin film resistors, organic transistors andthe like. The sensors 14 can include ceramics to enclose theelectronics. Additionally, the sensors 14 can include drug elutingcoatings, including but not limited to, an antibiotic, anti-inflammatoryagent and the like.

A wide variety of different sensors 14 can be utilized, including butnot limited to, bioimpedance, heart rate, heart rhythm, HRV, HRT, heartsounds, respiration rate, respiration rate variability, respiratorysounds, SpO2, blood pressure, activity, posture, wake/sleep, orthopnea,temperature, heat flux and an accelerometer. A variety of activitysensors can be utilized, including but not limited to a, ball switch,accelerometer, minute ventilation, HR, bioimpedance noise, skintemperature/heat flux, BP, muscle noise, posture and the like.

The outputs of the sensors 14 can have multiple features to enhancephysiological sensing performance. These multiple features have multiplesensing vectors that can include redundant vectors. The sensors caninclude current delivery electrodes and sensing electrodes. Size andshape of current delivery electrodes, and the sensing electrodes, can beoptimized to maximize sensing performance. The system 10 can beconfigured to determine an optimal sensing configuration andelectronically reposition at least a portion of a sensing vector of asensing electrode. The multiple features enhance the ability of system10 to determine an optimal sensing configuration and electronicallyreposition sensing vectors. In one embodiment, the sensors 14 can bepartially masked to minimize contamination of parameters sensed by thesensors 14.

The size and shape of current delivery electrodes, for bioimpedance, andsensing electrodes can be optimized to maximize sensing performance.Additionally, the outputs of the sensors 14 can be used to calculate andmonitor blended indices. Examples of the blended indices include but arenot limited to, heart rate (HR) or respiratory rate (RR) response toactivity, HR/RR response to posture change, HR+RR, HR/RR+bioimpedance,and/or minute ventilation/accelerometer and the like.

The sensors 14 can be cycled in order to manage energy, and differentsensors 14 can sample at different times. By way of illustration, andwithout limitation, instead of each sensor 14 being sampled at aphysiologically relevant interval, e.g. every 30 seconds, one sensor 14can be sampled at each interval, and sampling cycles between availablesensors.

By way of illustration, and without limitation, the sensors 14 cansample no more than 30 seconds for every minute for ECG, no more thanonce a second for an accelerometer sensor, and no more than 60 secondsfor every 15 minutes for bio-impedance.

In one embodiment, a first of sensors 14 comprises a core sensor thatcontinuously monitors and detects, and a second of sensors 14 verifies aphysiological status in response to the core sensor 14 raising a flag.Additionally, at least some of sensors 14 can be used for short termtracking, and other sensors of sensor 14 used for long term tracking.

Referring to FIG. 6, in one embodiment, an external device 38, which maycomprise a medical treatment device, is coupled to the sensors 14. Theexternal device 38 can be coupled to a monitoring unit 22 that is partof the detecting system 12, or in direct communication with the sensors14. A variety of different external devices 38 can be used to monitorand/or treat the patient, the external devices 38 including but notlimited to, a weight scale, blood pressure cuff, cardiac rhythmmanagement device, a medical treatment device, medicament dispenser andthe like. Suitable cardiac rhythm management devices include but are notlimited to, Boston Scientific's Latitude system, Medtronic's C are Linksystem, St. Jude Medical's HouseCall system and the like. Suchcommunication may occur directly, or via an external translator unit.

Referring again to FIG. 6, the external device 38 can be coupled to anauxiliary input of the monitoring unit 22 at the detecting system 12 orto the monitoring system 22 at the remote monitoring system 18.Additionally, an automated reader can be coupled to an auxiliary inputin order to allow a single monitoring unit 22 to be used by multiplepatients. As previously mentioned above, the monitoring unit 22 can beat the remote monitoring system 18 and each patient can have a patientidentifier (ID) including a distinct patient identifier. In addition,the ID identifier can also contain patient specific configurationparameters. The automated reader can scan the patient identifier ID andtransmit the patient ID number with a patient data packet such that themain data collection station can identify the patient.

It will be appreciated that other medical treatment devices can also beused. The sensors 14 can communicate wirelessly with the externaldevices 38 in a variety of ways including but not limited to, a publicor proprietary communication standard and the like. The detecting system12 comprising sensors 14 can be configured to serve as a communicationhub for multiple medical devices, coordinating sensor data and therapydelivery while transmitting and receiving data from the remotemonitoring system 18.

In one embodiment, the detecting system 12 comprising sensors 14 isconfigured to coordinate data sharing between the external systems 38allowing for sensor integration across devices. The coordination of thesensors 14 provides for new pacing, sensing, defibrillation vectors andthe like.

In one embodiment, the processor 20 is included in the monitoring unit22 and the external device 38 is in direct communication with themonitoring unit 22.

In another embodiment, illustrated in FIG. 7, a notification device 42is coupled to the detecting system 12 and the remote monitoring system18. The notification device 42 is configured to provide notificationwhen values received from the sensors 14 are not within acceptablephysiological ranges. The notification device 42 can be at the remotemonitoring system 18 or at the monitoring unit 22 that is part of thedetecting system 12. A variety of notification devices 42 can beutilized, including but not limited to, a visible patient indicator, anaudible alarm, an emergency medical service notification, a call centeralert, direct medical provider notification and the like. Thenotification device 42 provides notification to a variety of differententities, including but not limited to, the patient, a caregiver, theremote monitoring system, a spouse, a family member, a medical provider,from one device to another device such as the external device 38, andthe like.

Notification can be according to a preset hierarchy. By way ofillustration, and without limitation, the preset hierarchy can be,patient notification first and medical provider second, patientnotification second and medical provider first, and the like. Uponreceipt of a notification, a medical provider, the remote monitoringsystem 18, or a medical treatment device can trigger a high-ratesampling of physiological parameters for alert verification.

The system 10 can also include an alarm 46, that can be coupled to thenotification device 42, for generating a human perceptible signal whenvalues received from the sensors 14 are not within acceptablephysiological ranges. The alarm 46 can trigger an event to rendermedical assistance to the patient, provide notification as set forthabove, continue to monitor, wait and see, and the like.

When the values received from the sensors 14 are not within acceptablephysiological ranges the notification is with the at least one of, thepatient, a spouse, a family member, a caregiver, a medical provider andfrom one device to another device, to allow for therapeutic interventionto prevent decompensation, and the like.

In another embodiment, the sensors 14 can switch between differentmodes, wherein the modes are selected from at least one of, a standalone mode with communication directly with the remote monitoring system18, communication with an implanted device, communication with a singleimplanted device, coordination between different devices (externalsystems) coupled to the plurality of sensors and different devicecommunication protocols.

By way of illustration, and without limitation, the patient can be acongestive heart failure patient. Heart failure status is determined bya weighted combination change in sensor outputs and be determined by anumber of different means, including but not limited to, (i) when a rateof change of at least two sensor outputs is an abrupt change in thesensor outputs as compared to a change in the sensor outputs over alonger period of time, (ii) by a tiered combination of at least a firstand a second sensor output, with the first sensor output indicating aproblem that is then verified by at least a second sensor output, (iii)by a variance from a baseline value of sensor outputs, and the like. Thebaseline values can be defined in a look up table.

In another embodiment, heart failure status is determined using three ormore sensors by at least one of, (i) when the first sensor output is ata value that is sufficiently different from a baseline value, and atleast one of the second and third sensor outputs is at a value alsosufficiently different from a baseline value to indicate heart failurestatus, (ii) by time weighting the outputs of the first, second andthird sensors, and the time weighting indicates a recent event that isindicative of the heart failure status and the like.

In one embodiment, the wireless communication device 16 can include a,modem, a controller to control data supplied by the sensors 14, serialinterface, LAN or equivalent network connection and a wirelesstransmitter. Additionally, the wireless communication device 16 caninclude a receiver and a transmitter for receiving data indicating thevalues of the physiological event detected by the plurality of sensors,and for communicating the data to the remote monitoring system 18.Further, the wireless communication device 16 can have data storage forrecording the data received from the sensors 14 and an access device forenabling access to information recording in the data storage from theremote monitoring system 18.

In various embodiments, the remote monitoring system 18 can include areceiver, a transmitter and a display for displaying data representativeof values of the one physiological event detected by the sensors 14. Theremote monitoring system can also include a, data storage mechanism thathas acceptable ranges for physiological values stored therein, acomparator for comparing the data received from the monitoring system 12with the acceptable ranges stored in the data storage device and aportable computer. The remote monitoring system 18 can be a portableunit with a display screen and a data entry device for communicatingwith the wireless communication device 16.

Referring now to FIG. 8, for each of sensors 14, a sensor lead 112 and114 conveys signals from the sensor 14 to the monitoring unit 22 at thedetecting system 12, or through the wireless communication device 16 tothe remote monitoring system 18, or both. In one embodiment, each signalfrom a sensor 14 is first passed through a filter 116, such a low-passfilter, at the detecting system 12 or at the remote monitoring system18, to smooth the signal and reduce noise. The signal is thentransmitted to an analog-to-digital converter 118A, which transforms thesignals into a stream of digital data values that can be stored in adigital memory 118B. From the digital memory 118B, data values aretransmitted to a data bus 120, along which they are transmitted to othercomponents of the circuitry to be processed and archived. From the databus 120, the digital data can be stored in a non-volatile data archivememory. The digital data can be transferred via the data bus 120 to theat least one processor 20, which processes the data based in part onalgorithms and other data stored in a non-volatile program memory.

The detecting system 12 can also include a power management module 122configured to power down certain components of the system, including butnot limited to, the analog-to-digital converters 118A, digital memories118B and the non-volatile data archive memory and the like, betweentimes when these components are in use. This helps to conserve batterypower and thereby extend the battery life. Other circuitry and signalingmodes may be devised by one skilled in the art.

As can be seen in FIG. 9, a control unit 126 is included at thedetecting system 12, the remote monitoring system 18 or at bothlocations.

In one embodiment, the control unit 126 can be a known 486microprocessor, available from Intel, Inc. of Santa Clara, Calif. Thecontrol unit 126 can be coupled to the sensors 14 directly at thedetecting system 12, indirectly at the detecting system 12 or indirectlyat the remote monitoring system 18. Additionally the control unit 126can be coupled to a blood pressure monitor, a cardiac rhythm managementdevice, a scale or a device that dispenses medication that can indicatethe medication has been dispensed.

The control unit 126 can be powered by AC inputs which are coupled tointernal AC/DC converters 134 that generate multiple DC voltage levels.After the control unit 126 has collected the patient data from thesensors 14, the control unit 126 encodes the recorded patient data andtransmits the patient data through the wireless communication device 16to transmit the encoded patient data to a wireless network storage unit128 at the remote monitoring system 18 as shown in FIG. 10. In anotherembodiment, wireless communication device 16 transmits the patient datafrom the sensors 14 to the control unit 126 when it is at the remotemonitoring system 18.

Each time the control unit 126 plans to transmit patient data to a maindata collection station 130, located at the remote monitoring system 18,the control unit 126 attempts to establish a communication link. Thecommunication link can be wireless, wired, or a combination of wirelessand wired for redundancy, e.g., the wired link checks to see if awireless communication can be established. If the wireless communicationlink 16 is available, the control unit 126 transmits the encoded patientdata through the wireless communication device 16. However, if thewireless communication device 16 is not available for any reason, thecontrol unit 126 waits and tries again until a link is established.

Referring now to FIG. 10 and FIG. 11, one embodiment of an internalstructure of a main data collection station 130, at the remotemonitoring system 18, is illustrated. The patient data can betransmitted to the remote monitoring system 18 by either the wirelesscommunication device 16 or conventional modem to the wireless networkstorage unit 128. After receiving the patient data, the wireless networkstorage unit 128 can be accessed by the main data collection station130. The main data collection station 130 allows the remote monitoringsystem 18 to monitor the patient data of numerous patients from acentralized location without requiring the patient or a medical providerto physically interact with each other.

The main data collection station 130 can include a communications server136 that communicates with the wireless network storage unit 128. Thewireless network storage unit 128 can be a centralized computer serverthat includes a unique, password protected mailbox assigned to andaccessible by the main data collection station 130. The main datacollection station 130 communicates with the wireless network storageunit 128 and downloads the patient data stored in a mailbox assigned tothe main data collection station 130.

Once the communications server 136 has formed a link with the wirelessnetwork storage unit 128, and has downloaded the patient data, thepatient data can be transferred to a database server 138. The databaseserver 138 includes a patient database 140 that records and stores thepatient data of the patients based upon identification included in thedata packets sent by each of the monitoring units 22. For example, eachdata packet can include an identifier.

Each data packet transferred from the remote monitoring system 18 to themain data collection station 130 does not have to include any patientidentifiable information. Instead, the data packet can include theserial number assigned to the specific detecting system 12. The serialnumber associated with the detecting system 12 can then be correlated toa specific patient by using information stored on the patient database138. In this manner, the data packets transferred through the wirelessnetwork storage unit 128 do not include any patient-specificidentification. Therefore, if the data packets are intercepted orimproperly routed, patient confidentiality can not be breached.

The database server 138 can be accessible by an application server 142.The application server 142 can include a data adapter 144 that formatsthe patient data information into a form that can be viewed over aconventional web-based connection. The transformed data from the dataadapter 144 can be accessible by propriety application software througha web server-146 such that the data can be viewed by a workstation 148.The workstation 148 can be a conventional personal computer that canaccess the patient data using proprietary software applications through,for example, HTTP protocol, and the like.

The main data collection station further can include an escalationserver 150 that communicates with the database server 138. Theescalation server 150 monitors the patient data packets that arereceived by the database server 138 from the monitoring unit 22.Specifically, the escalation server 150 can periodically poll thedatabase server 138 for unacknowledged patient data packets. The patientdata packets are sent to the remote monitoring system 18 where theprocessing of patient data occurs. The remote monitoring system 18communicates with a medical provider if the event that an alert isrequired. If data packets are not acknowledged by the remote monitoringsystem 18. The escalation server 150 can be programmed to automaticallydeliver alerts to a specific medical provider if an alarm message hasnot been acknowledged within a selected time period after receipt of thedata packet.

The escalation server 150 can be configured to generate the notificationmessage to different people by different modes of communication afterdifferent delay periods and during different time periods.

The main data collection station 130 can include a batch server 152connected to the database server 138. The batch server 152 allows anadministration server 154 to have access to the patient data stored inthe patient database 140. The administration server allows forcentralized management of patient information and patientclassifications.

The administration server 154 can include a batch server 156 thatcommunicates with the batch server 152 and provides the downloaded datato a data warehouse server 158. The data warehouse server 158 caninclude a large database 160 that records and stores the patient data.

The administration server 154 can further include an application server162 and a maintenance workstation 148 that allow personnel from anadministrator to access and monitor the data stored in the database 160.

The data packet utilized in the transmission of the patient data can bea variable length ASCII character packet, or any generic data formats,in which the various patient data measurements are placed in a specificsequence with the specific readings separated by commas. The controlunit 126 can convert the readings from each sensor 14 into astandardized sequence that forms part of the patient data packet. Inthis manner, the control unit 126 can be programmed to convert thepatient data readings from the sensors 14 into a standardized datapacket that can be interpreted and displayed by the main data collectionstation 130 at the remote monitoring system 18.

Referring now to the flow chart and method of operation shown in FIG.12, if an external device 38 fails to generate a valid reading, asillustrated in step A, the control unit 126 fills the portion of thepatient data packet associated with the external device 38 with a nullindicator. The null indicator can be the lack of any characters betweencommas in the patient data packet. The lack of characters in the patientdata packet can indicate that the patient was not available for thepatient data recording. The null indicator in the patient data packetcan be interpreted by the main data collection station 130 at the remotemonitoring system 18 as a failed attempt to record the patient data dueto the unavailability of the patient, a malfunction in one or more ofthe sensors 14, or a malfunction in one of the external devices 38. Thenull indicator received by the main data collection station 130 canindicate that the transmission from the detecting system 12 to theremote monitoring system 18 was successful. In one embodiment, theintegrity of the data packet received by the main data collectionstation 130 can be determined using a cyclic redundancy code, CRC-16,check sum algorithm. The check sum algorithm can be applied to the datawhen the message can be sent and then again to the received message.

After the patient data measurements are complete, the control unit 126displays the sensor data, including but not limited to blood pressurecuff data and the like, as illustrated by step B. In addition todisplaying this data, the patient data can be placed in the patient datapacket, as illustrated in step C.

As previously described, the system 10 can take additional measurementsutilizing one or more auxiliary or external devices 38 such as thosementioned previously. Since the patient data packet has a variablelength, the auxiliary device patient information can be added to thepatient data packet being compiled by the remote monitoring unit 22during patient data acquisition period being described. Data from theexternal devices 38 is transmitted by the wireless communication device16 to the remote monitoring system 18 and can be included in the patientdata packet.

If the remote monitoring system 18 can be set in either the auto mode orthe wireless only mode, the remote monitoring unit 22 can firstdetermine if there can be an internal communication error, asillustrated in step D.

A no communication error can be noted as illustrated in step E. If acommunication error is noted the control unit 126 can proceed towireless communication device 16 or to a conventional modem transmissionsequence, as will be described below. However, if the communicationdevice is working the control unit 126 can transmit the patient datainformation over the wireless network 16, as illustrated in step F.After the communication device has transmitted the data packet, thecontrol unit 126 determines whether the transmission was successful, asillustrated in step G. If the transmission has been unsuccessful onlyonce, the control unit 126 retries the transmission. However, if thecommunication device has failed twice, as illustrated in step H, thecontrol unit 126 proceeds to the conventional modem process if theremote monitoring unit 22 was configured in an auto mode.

When the control unit 126 is at the detecting system 12, and the controlunit 126 transmits the patient data over the wireless communicationdevice 16, as illustrated in step I, if the transmission has beensuccessful, the display of the remote monitoring unit 22 can display asuccessful message, as illustrated in step J. However, if the controlunit 126 determines in step K that the communication of patient data hasfailed, the control unit 126 repeats the transmission until the controlunit 126 either successfully completes the transmission or determinesthat the transmission has failed a selected number of times, asillustrated in step L. The control unit 126 can time out the and afailure message can be displayed, as illustrated in steps M and N. Oncethe transmission sequence has either failed or successfully transmittedthe data to the main data collection station, the control unit 126returns to a start program step, for example step A.

The processor system, as described above, can be configured to performthe method shown in FIG. 12, including many of the steps describedabove. It should be appreciated that the specific steps illustrated inFIG. 12 provide a particular method, according to one embodiment of thepresent invention. Other sequences of steps may also be performedaccording to alternative embodiments. For example, alternativeembodiments of the present invention may perform the steps outlinedabove in a different order. Moreover, the individual steps illustratedin FIG. 12 may include multiple sub-steps that may be performed invarious sequences as appropriate to the individual step. Furthermore,additional steps may be added or removed depending on the particularapplications. One of ordinary skill in the art would recognize manyvariations, modifications, and alternatives.

Referring again to FIG. 11, the patient data packets are first sent andstored in the wireless network storage unit 128. From there, the patientdata packets are downloaded into the main data collection station 130.The main data collection station 130 decodes the encoded patient datapackets and records the patient data in the patient database 140. Thepatient database 140 can be divided into individual storage locationsfor each patient such that the main data collection station 130 canstore and compile patient data information from a plurality ofindividual patients.

A report on the patient's status can be accessed by a medical providerthrough a medical provider workstation that is coupled to the remotemonitoring system 18. Unauthorized access to the patient database can beprevented by individual medical provider usernames and passwords toprovide additional security for the patient's recorded patient data.

The main data collection station 130 and the series of work stations 148allow the remote monitoring system 18 to monitor the daily patient datameasurements taken by a plurality of patients reporting patient data tothe single main data collection station 130. The main data collectionstation 130 can be configured to display multiple patients on thedisplay of the workstations 148. The internal programming for the maindata collection station 130 can operate such that the patients areplaced in a sequential top-to-bottom order based upon whether or not thepatient can be generating an alarm signal for one of the patient databeing monitored. For example, if one of the patients monitored bymonitoring system 130 has a blood pressure exceeding a predeterminedmaximum amount, this patient can be moved toward the top of the list ofpatients and the patient's name and/or patient data can be highlightedsuch that the medical personnel can quickly identify those patients whomay be in need of medical assistance. By way of illustration, andwithout limitation, the following paragraphs are a representative orderranking method for determining the order which the monitored patientsare displayed:

Alarm Display Order Patient Status Patients are then sorted: 1 MedicalAlarm Most alarms violated to least alarms violated, then oldest tonewest 2 Missing Data Alarm Oldest to newest 3 Late Oldest to newest 4Reviewed Medical Alarms Oldest to newest 5 Reviewed Missing Data Oldestto newest Alarms 6 Reviewed Null Oldest to newest 7 NDR Oldest to newest8 Reviewed NDR Oldest to newest.

Alarm Display Order Patient Status Patients can then be sorted: 1Medical Alarm Most alarms violated to least alarms violated, then oldestto newest 2 Missing Data Alarm Oldest to newest 3 Late Oldest to newest4 Reviewed Medical Alarms Oldest to newest 5 Reviewed Missing DataOldest to newest Alarms 6 Reviewed Null Oldest to newest 7 NDR Oldest tonewest 8 Reviewed NDR Oldest to newest.

As listed in the above, the order of patients listed on the display canbe ranked based upon the seriousness and number of alarms that areregistered based upon the latest patient data information. For example,if the blood pressure of a single patient exceeds the tolerance leveland the patient's heart rate also exceeds the maximum level, thispatient will be placed above a patient who only has one alarm condition.In this manner, the medical provider can quickly determine which patientmost urgently needs medical attention by simply identifying thepatient's name at the top of the patient list. The order which thepatients are displayed can be configurable by the remote monitoringsystem 18 depending on various preferences.

As discussed previously, the escalation server 150 automaticallygenerates a notification message to a specified medical provider forunacknowledged data packets based on user specified parameters.

Referring again to FIG. 9, in addition to displaying the current patientdata for the numerous patients being monitored, the software of the maindata collection station 130 allows the medical provider to trend thepatient data over a number of prior measurements in order to monitor theprogress of a particular patient. In addition, the software allows themedical provider to determine whether or not a patient has beensuccessful in recording their patient data as well as monitor thequestions being asked by the remote monitoring unit 22.

As previously mentioned, the system 10 uses an intelligent combinationof sensors to enhance detection and prediction capabilities.Electrocardiogram circuitry can be coupled to the sensors 14, orelectrodes, to measure an electrocardiogram signal of the patient. Anaccelerometer can be mechanically coupled, for example adhered oraffixed, to the sensors 14, adherent patch and the like, to generate anaccelerometer signal in response to at least one of an activity or aposition of the patient. The accelerometer signals improve patientdiagnosis, and can be especially useful when used with other signals,such as electrocardiogram signals and impedance signals, including butnot limited to, hydration, respiration, and the like. Mechanicallycoupling the accelerometer to the sensors 14, electrodes, for measuringimpedance, hydration and the like can improve the quality and/orusefulness of the impedance and/or electrocardiogram signals. By way ofillustration, and without limitation, mechanical coupling of theaccelerometer to the sensors 14, electrodes, and to the skin of thepatient can improve the reliability, quality and/or accuracy of theaccelerometer measurements, as the sensor 14, electrode, signals canindicate the quality of mechanical coupling of the patch to the patientso as to indicate that the device is connected to the patient and thatthe accelerometer signals are valid. Other examples of sensorinteraction include but are not limited to, (i) orthopnea measurementwhere the breathing rate is correlated with posture during sleep, anddetection of orthopnea, (ii) a blended activity sensor using therespiratory rate to exclude high activity levels caused by vibration(e.g. driving on a bumpy road) rather than exercise or extreme physicalactivity, (iii) sharing common power, logic and memory for sensors,electrodes, and the like.

The signals from the plurality of sensors can be combined in many ways.In some embodiments, the signals can be used simultaneously to determinean impending cardiac decompensation.

In some embodiments, the signals can be combined by using the at leasttwo of the electrocardiogram signal, the respiration signal or theactivity signal to look up a value in a previously existing array.

TABLE 1 Lookup Table for ECG and Respiration Signals. HeartRate/Respiration A-B bpm C-D bpm E-F bpm U-V per min N N Y W-X per min NY Y Y-Z per min Y Y Y

Table 1 shows combination of the electrocardiogram signal with therespiration signal to look up a value in a pre-existing array. Forexample, at a heart rate in the range from A to B bpm and a respirationrate in the range from U to V per minute triggers a response of N. Insome embodiments, the values in the table may comprise a tier or levelof the response, for example four tiers. In specific embodiments, thevalues of the look up table can be determined in response to empiricaldata measured for a patient population of at least about 100 patients,for example measurements on about 1000 to 10,000 patients. The look uptable shown in Table 1 illustrates the use of a look up table accordingto one embodiment, and one will recognize that many variables can becombined with a look up table.

In some embodiments, the table may comprise a three or more dimensionallook up table, and the look up table may comprises a tier, or level, ofthe response, for example an alarm.

In some embodiments, the signals may be combined with at least one ofadding, subtracting, multiplying, scaling or dividing the at least twoof the electrocardiogram signal, the respiration signal or the activitysignal. In specific embodiments, the measurement signals can be combinedwith positive and or negative coefficients determined in response toempirical data measured for a patient population of at least about 100patients, for example data on about 1000 to 10,000 patients.

In some embodiments, a weighted combination may combine at least twomeasurement signals to generate an output value according to a formulaof the general form

OUTPUT=aX+bY

where a and b comprise positive or negative coefficients determined fromempirical data and X, and Z comprise measured signals for the patient,for example at least two of the electrocardiogram signal, therespiration signal or the activity signal. While two coefficients andtwo variables are shown, the data may be combined with multiplicationand/or division. One or more of the variables may be the inverse of ameasured variable.

In some embodiments, the ECG signal comprises a heart rate signal thatcan be divided by the activity signal. Work in relation to embodimentsof the present invention suggest that an increase in heart rate with adecrease in activity can indicate an impending decompensation. Thesignals can be combined to generate an output value with an equation ofthe general form

OUTPUT=aX/Y+bZ

where X comprise a heart rate signal, Y comprises an activity signal andZ comprises a respiration signal, with each of the coefficientsdetermined in response to empirical data as described above.

In some embodiments, the data may be combined with a tiered combination.While many tiered combinations can be used a tiered combination withthree measurement signals can be expressed as

OUTPUT=(ΔX)+(ΔY)+(ΔZ)

where (ΔX), (ΔY), (ΔZ) may comprise change in heart rate signal frombaseline, change in respiration signal from baseline and change inactivity signal from baseline, and each may have a value of zero or one,based on the values of the signals. For example if the heart rateincreases by 10%, (ΔX) can be assigned a value of 1. If respirationincreases by 5%, (ΔY) can be assigned a value of 1. If activitydecreases below 10% of a baseline value (ΔZ) can be assigned a valueof 1. When the output signal is three, a flag may be set to trigger analarm.

In some embodiments, the data may be combined with a logic gatedcombination. While many logic gated combinations can be used, a logicgated combination with three measurement signals can be expressed as

OUTPUT=(ΔX) AND (ΔY) AND (ΔZ)

where (ΔX), (ΔY), (ΔZ) may comprise change in heart rate signal frombaseline, change in respiration signal from baseline and change inactivity signal from baseline, and each may have a value of zero or one,based on the values of the signals. For example if the heart rateincreases by 10%, (ΔX) can be assigned a value of 1. If respirationincreases by 5%, (ΔY) can be assigned a value of 1. If activitydecreases below 10% of a baseline value (ΔZ) can be assigned a valueof 1. When each of (ΔX), (ΔY), (ΔZ) is one, the output signal is one,and a flag may be set to trigger an alarm. If any one of (ΔX), (ΔY) or(ΔZ) is zero, the output signal is zero and a flag may be set so as notto trigger an alarm. While a specific example with AND gates has beenshown the data can be combined in may ways with known gates for exampleNAND, NOR, OR, NOT, XOR, XNOR gates. In some embodiments, the gatedlogic may be embodied in a truth table.

The adherent patch device, as described above, can be configured forcontinuous placement on the patient for and extended period, for exampleat least one week. The plurality of sensors, the wireless communicationcircuitry on the patch and the processor on the patch can be configuredwith duty cycles, such that the patient is monitored for at least oneweek and battery of the adherent patch will last for at least one week.Table II shows a configuration of the plurality of sensors, the wirelesscommunication circuitry and duty cycles configured to monitor thepatient for at least one week. The circuitry components shown in TableII may comprise known circuitry components, for example known ECG and HRcircuitry, known Bioimpedance and Respiration Circuitry, knownAccelerometer Circuitry, known Temperature Sensor Circuitry, Known FlashMemory Circuitry, known Processor Circuitry and known WirelessCircuitry. The power consumption of these known circuitry components canbe used to analyze the performance of the patch.

TABLE II Duty cycle of patch device components for a one week patch.Current Consumed Patch Device Sampling Time and Duty (mAseconds perComponent Interval Cycle % Day) ECG Circuitry 20 s per minute 36.818,670 Bioimpedance 30 s per 15 minutes 4.4 30,639 CircuitryAccelerometer 1 ms per 2-4 s 0.0006 0.21 Circuitry Temperature 1 ms per1 minute 1.3E−05 0.018 Sensor Circuitry Flash Memory As needed 0.0034 23Processor 500 ms per second 52 541,843 Wireless 2-3 minutes per 4 0.5631,333 (BlueTooth) Circuitry hours

As shown in Table II, most of the measurement circuitry comprises a dutycycle of no more than 50%, and the processor circuitry comprises a dutycycle of about 50% and the wireless communication circuitry comprises aduty cycle of no more than about 1%. The duty cycle of the wirelesscommunication circuitry can be increased from 0.5% to at least about 1%,for example to about 3%, without significantly effecting the totalcurrent consumed. The total energy consumed per day for theconfiguration shown in Table II is about 170 mA Hours. A commerciallyavailable battery having a capacity of 1500 mA Hours will last about 8days. This cycling of the measurement circuitry can allow the adherentdevice to monitor a patient, for example a heart failure patient, for atleast about 1 week with the patch continuously adhered to the patient.In some embodiments, the duty cycle of the wireless communicationcircuitry can be increased, for example to about 5% and slightly largerbattery used to provide a useful life of one week with the adherentpatch continuously adhered to the patient. The data in Table II showthat a heart failure patient can be continuously monitored with sensorcycling for an extended period of at least about one week and withwireless transmission of no more than about 5% when the adherent patchis adhered to the skin of the patient.

While the exemplary embodiments have been described in some detail, byway of example and for clarity of understanding, those of skill in theart will recognize that a variety of modifications, adaptations, andchanges may be employed. Hence, the scope of the present inventionshould be limited solely by the appended claims.

1. A system for monitoring a patient, the system comprising: a patientdetecting system for measuring the patient including, an adherent deviceconfigured to be coupled to a patient, the adherent device comprising aplurality of sensors to measure physiological parameters of the patientto determine physiologic status of the patient, an energy managementdevice coupled to the plurality of sensors; a wireless communicationdevice coupled to the plurality of sensors; and a remote monitoringsystem coupled to the wireless communication device, wherein wirelesscommunication device is configured to transfer patient data from theplurality of sensors to the remote monitoring system.
 2. The system ofclaim 1, further comprising an energy generation device coupled to theenergy management device.
 3. The system of claim 1, wherein the energymanagement device is part of the patient detecting system.
 4. The systemof claim 1, wherein the adherent device is configured to sampleintermittently.
 5. The system of claim 4, wherein the plurality ofsensors are configured to sample no more than 30 seconds for everyminute for ECG, no more than once per second for an accelerometer sensorand no more than 60 seconds for every 15 minutes for impedance.
 6. Thesystem of claim 1, wherein the plurality of sensors is configured tomeasure at least one of bioimpedance, heart rate, heart rhythm, HRV,HRT, heart sounds, respiratory sounds, blood pressure, activity,posture, wake/sleep, orthopnea, temperature, heat flux or patientactivity.
 7. The system of claim 6, wherein the plurality of sensor isconfigured to measure the patient activity with at least one of a ballswitch, an accelerometer, minute ventilation, heart rate, bioimpedance,noise, skin temperature, heat flux, blood pressure, muscle noise orpatient posture.
 8. The system of claim 1, wherein the plurality ofsensors is configured to switch between different modes, the differentmodes comprising a first mode and a second mode, the first modedifferent from the second mode.
 9. The system of claim 1, wherein theenergy management device is configured to deactivate selected sensors toreduce redundancy and reduce power consumption.
 10. The system of claim1, wherein the energy management device is configured to use sensorcycling for energy management.
 11. The system of claim 10, wherein theplurality of sensors comprises a first portion of sensors and a secondportion of sensors and wherein the first portion is configured to sampleat first times the second portion is configured to sample at secondtimes.
 12. The system of claim 11, wherein the first times are differentfrom the second times, and wherein the energy management device isconfigured to cycle sampling between the first sensors and the secondsensors.
 13. The system of claim 1, wherein the plurality of sensorscomprises a first core sensor and a second sensor, the first core sensorconfigured to continuously monitor and detect, the second sensorconfigured to verify a physiological status in response to the coresensor raising a flag.
 14. The system of claim 1, wherein the pluralityof sensors comprises a first portion and a second portion, the firstportion different from the second portion, and wherein the first portionof sensor are configured for short term tracking, and the second portionof the sensors are configured for long term tracking.
 15. The system ofclaim 1, wherein the adherent device is configured to be activated. 16.The system of claim 15, wherein the adherent device is activated by atleast one of, a physiological trigger, automatic impedance, a tab pull,battery insertion, a hall or reed switch, a breakable glass capsule, adome switch, by light activation, pressure activation, body temperatureactivation, a connection between electronics associated with the sensorsand the adherent device, exposure to air and by a capacitive skinsensor.
 17. The system of claim 1, wherein the energy management deviceis configured to perform at least one of modulate a clock speed tooptimize energy, monitor cell voltage drop—unload cell, monitorcoulomb-meter or other battery monitor, battery end of life dropoff totransfer data, elective replacement indicator, call center notification,sensing windows by the sensors based on a monitored physiologicalparameter or sensing rate control.
 18. The system of claim 2, whereinthe energy generation device is configured to generate energy by atleast one of, a thermo-electric unit, kinetics, fuel cell, through solarpower, a zinc air interface, Faraday generator, internal combustion, amicro-battery and with a rechargeable device.
 19. The system of claim 1,further comprising: a processor comprising a tangible medium coupled tothe plurality of sensors and to the wireless communication device, theprocessor configured to receive patient data from the plurality ofsensors and process the patient data.
 20. The system of claim 19,wherein the processor is located at the remote monitoring system. 21.The system of claim 19, wherein the processor is included in amonitoring unit, the monitoring unit comprising part of the patientdetecting system.
 22. The system of claim 1, further comprising: logicresources located at the remote monitoring system to determine aphysiological status of the patient and detect a physiological event ofa patient.
 23. The system of claim 21, further comprising: logicresources located at the monitoring unit that determine a physiologicalevent of a patient.
 24. The system of claim 1, further comprising aprocessor system comprising a tangible medium and wherein the processorsystem has program instructions for evaluating values received from theplurality of sensors with respect to acceptable physiological ranges foreach value received by the processor.
 25. The system of claim 1, whereinthe wireless communication device is configured to receive instructionaldata from the remote monitoring system.
 26. The system of claim 1,wherein the wireless communication device comprises at least one of amodem, a serial interface, a LAN connection and a wireless transmitter.27. The system of claim 1, wherein the wireless communication deviceincludes a receiver and a transmitter for receiving data indicating thevalues of the physiological event detected by the plurality of sensors,and for communicating the data to the remote monitoring system.
 28. Thesystem of claim 1, wherein the wireless communication device comprises awireless local area network for receiving data from the plurality ofsensors.
 29. The system of claim 1, wherein the wireless communicationdevice includes a data storage for recording the data received from theplurality of sensors.
 30. The system of claim 29, wherein the wirelesscommunication device includes an access device for enabling access toinformation recorded in the data storage from the remote monitoringsystem.
 31. The system of claim 1, wherein the wireless communicationdevice includes a controller configured to control sending of the datasupplied by the plurality of sensors.
 32. The system of claim 1, furthercomprising: an external device coupled to the adherent device comprisingthe plurality of sensors.
 33. The system of claim 32, wherein theexternal device comprises at least one of a weight scale, a bloodpressure cuff, a medical treatment device or a medicament dispenser. 34.The system of claim 1, further comprising: a notification device coupledto the patient detecting system and the remote monitoring system, thenotification device configured to provide a notification when valuesreceived from the plurality of sensors are outside acceptablephysiological ranges.
 35. The system of claim 34, wherein the patientmeasurement system is configured to measure physiological parameters ata high-rate of sampling in response to a trigger from at least one of amedical provider, the remote monitoring system or a medical treatmentdevice and wherein the at least one of the medical provider, the remotemonitoring system or the medical treatment device are configured totrigger the high-rate of sampling of the physiological parameters foralert verification.
 36. The system of claim 34, wherein the notificationdevice is configured to communicate with the at least one of thepatient, a clinician, a spouse, a family member, a caregiver or amedical provider when the values received from the plurality of sensorsare not within acceptable physiological ranges and configured tocommunicate from one device to another device, to allow for therapeuticintervention to prevent decompensation when the values received from theplurality of sensors are not within acceptable physiological ranges. 37.The system of claim 1, further comprising: a memory management device.38. The system of claim 37, wherein the memory management device isconfigured to perform at least one of data compression, prioritizing ofsensing by a sensor, monitoring at least some from at least some of thesensors, sensing by the sensors in real time, noise blanking such thatsensor data is not stored when noise above a selected level isdetermined, low-power of battery caching or decimation of old sensordata.
 39. The system of claim 1, wherein the adherent device comprises awearable patch that includes a battery.
 40. The system of claim 1,wherein the physiological status of the patient comprises a heartfailure status and wherein at least one of the patient detecting systemor the remote monitoring system comprises a processor system configuredto determine the heart failure status of the patient in response to thephysiological parameters.
 41. The system of claim 1, wherein theplurality of sensors comprises a combination of at least two sensorsconfigured to detect or predict decompensation and wherein thecombination comprising the at least two sensors is configure to measureat least two of an electrocardiogram signal, a hydration signal, anaccelerometer signal or a respiration signal of the patient.
 42. Thesystem of claim 1, wherein the remote monitoring system includes areceiver, a transmitter and a display for displaying data representativeof values of at least one physiological event detected by the pluralityof sensors.
 43. The system of claim 1, wherein the remote monitoringsystem includes a data storage mechanism having a plurality ofacceptable ranges for physiological values stored therein, and acomparator for comparing the data received from the monitoring systemwith the acceptable ranges stored in the data storage device.
 44. Thesystem of claim 1, wherein the remote monitoring system includes aportable computer.
 45. The system of claim 1, wherein the remotemonitoring system comprises a portable unit having a display screen anda data entry device for communicating with the wireless communicationdevice.
 46. A device for monitoring a patient, the device comprising: anadherent device configured to adhere to a skin of the patient, theadherent device comprising a plurality of sensors, sensor circuitrycoupled to the plurality of sensors, wireless circuitry and energymanagement circuitry, wherein the sensor circuitry compriseselectrocardiogram circuitry, bioimpedance circuitry, accelerometercircuitry, and temperature sensor circuitry, wherein the powermanagement device is coupled to the wireless circuitry and configured totransmit data from the sensor circuitry with a duty cycle of no morethan about 5%.
 47. The device of claim 46 wherein the device isconfigured to monitor a patient health status in response to theplurality of sensors.
 48. The device of claim 47 wherein the patientcomprises a heart failure patient and the adherent device is configuredto continuously monitor the heart failure status with the wirelesscircuitry duty cycle of no more than about 5%.
 49. The device of claim46 wherein a majority of the sensor circuitry comprises a duty cycle ofno more than about 5%.
 50. The device of claim 49 wherein theelectrocardiogram comprises a duty cycle of no more than about 40%, thebioimpedance circuitry comprises a duty cycle of no more than about 10%,the accelerometer circuitry comprises a duty cycle of no more than about1%, and the temperature sensor circuitry comprises a duty cycle of nomore than about 1%.
 51. The device of claim 46 wherein the powermanagement device comprises a timer coupled to the sensor circuitry todetermine the duty cycle of each sensor.
 52. The device of claim 51further comprising a processor comprising a tangible medium coupled tothe sensor circuitry and configured with the timer to sample data fromthe sensor circuitry and wherein the adherent device is configured tosupport the processor, the plurality of sensors, the sensor circuitry,the wireless circuitry and the energy management circuitry with the skinof the patient.
 53. The device of claim 52 wherein the processor isconfigured to determine heart rate in response to the electrocardiogramcircuitry.
 54. The device of claim 53 wherein the processor isconfigured to determine respiration in response to the bioimpedancecircuitry.
 55. The device of claim 53 further comprising a processorsystem, the processor system comprising the processor and a secondprocessor at a remote location, the second processor wirelessly coupledto the processor supported with adherent device, and wherein theprocessor system is configured to detect decompensation of a heartfailure patient in response to output from the plurality of sensors. 56.The device of claim 55 wherein the second processor at the remotelocation is configured to combine the output from the plurality ofsensors to detect the decompensation of the heart failure patient. 57.The device of claim 56 wherein the second processor at the remotelocation is configured to determine a respiration rate of the patient atthe remote location in response to the bioimpedance circuitry.
 58. Thedevice of claim 52 comprising at least one battery configured to powerthe electrocardiogram circuitry, the bioimpedance circuitry and theaccelerometer circuitry and the temperature sensor circuitry for atleast about one week when the adherent device is adhered to the skin ofthe patient.
 59. The device of claim 58 wherein the adherent device isconfigured to consume no more than about 1500 mA Hours per day when theadherent device is adhered to the patient for an extended period of atleast about one week.
 60. A method for monitoring a patient, the methodcomprising: adhering an adherent device to a skin of the patient, theadherent device comprising a plurality of sensors; measuring patientdata with sensor circuitry coupled to the plurality of sensors, whereinthe sensor circuitry comprises at least one of electrocardiogramcircuitry, bioimpedance circuitry, accelerometer circuitry, ortemperature sensor circuitry; and transmitting the patient data withwireless transmission circuitry supported the skin of the patient to aremote monitoring system and wherein the wireless transmission circuitrytransmits the patient data intermittently with a duty cycle of no morethan about 5%.